Asperflex Original Maximum Strength

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints associated with various conditions, including arthritis, simple backache, strains, sprains, and bruises.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For adults and children aged 12 years and older, the patch should be applied as follows: Gently fold the patch in half to remove the center section of the film backing. The exposed adhesive portion should then be applied directly to the site of pain. After this, the remaining film backing from both sides should be removed, ensuring the patch is fully adhered to the skin. The patch may be applied to the affected area no more than 3 to 4 times daily.

For children under 12 years of age, it is recommended to consult a doctor prior to application.

Contraindications

Use is contraindicated in the following situations:

Application is not permitted on wounds, damaged, broken, or irritated skin due to the risk of exacerbating the condition and causing further irritation. Additionally, the product should not be used in conjunction with other topical analgesics, as this may increase the risk of adverse effects. Tight bandaging or the application of local heat, such as heating pads or medicated patches, to the area of use is also contraindicated, as it may lead to increased absorption and potential toxicity.

Warnings and Precautions

For external use only. This product should not be applied to wounds, damaged, broken, or irritated skin. It is imperative to avoid the use of heating pads or the application of local heat to the area of use.

When utilizing this product, it is essential to adhere strictly to the provided directions. Healthcare professionals should instruct patients to read and follow all warnings and directions on the carton. Contact with the eyes and mucous membranes must be avoided. There have been rare reports of serious burns associated with similar products; therefore, caution is advised.

The product should not be applied to wounds or any compromised skin. Additionally, it is important not to bandage tightly or apply local heat, such as heating pads or medicated patches, to the area of application. Concurrent use with other topical analgesics is contraindicated. Patients may experience a transient burning sensation upon application, which typically resolves within several days. Care should be taken to avoid application in skin folds, and no more than four patches should be used simultaneously.

Patients should be advised to discontinue use and consult a physician if any of the following occur: the condition worsens or symptoms persist for more than seven days; symptoms resolve and then recur within a few days; severe burning sensation, redness, or irritation develops; or signs of skin injury, such as pain, swelling, or blistering, are observed at the application site.

In the event of ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center (1-800-222-1222) is recommended.

Side Effects

Patients using this product should be aware that it is intended for external use only. It should not be applied to wounds, damaged, broken, or irritated skin, nor should it be used in conjunction with heating pads or local heat applications.

During the use of this product, rare cases of serious burns have been reported with similar products. A transient burning sensation may occur upon application; however, this sensation typically resolves within several days. Patients are advised to avoid applying the product into skin folds and to limit the use to no more than four patches at a time.

Patients should discontinue use and consult a healthcare professional if the condition worsens or if symptoms persist for more than seven days. Additionally, if symptoms resolve and then recur within a few days, or if a severe burning sensation, redness, or irritation develops, medical advice should be sought. Signs of skin injury, such as pain, swelling, or blistering at the application site, also warrant immediate consultation with a healthcare provider.

It is important to avoid contact with the eyes and mucous membranes. Patients should not bandage the area tightly or apply local heat, including heating pads, to the site of application. Furthermore, the product should not be used simultaneously with other topical analgesics.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Asperflex Original Maximum Strength (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a doctor prior to use. For adolescents and children aged 12 years and older, the recommended application is to the affected area no more than 3 to 4 times daily.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the potential for altered pharmacokinetics and pharmacodynamics in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the prescribing information.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay. The national Poison Control Center can be reached at 1-800-222-1222.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective recovery.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional prior to use.

Rare instances of serious burns have been documented with products of this nature. A transient burning sensation may occur upon application; however, this sensation typically resolves within several days. Users are instructed to discontinue use and seek medical advice if a severe burning sensation, redness, or irritation develops. Additionally, if signs of skin injury such as pain, swelling, or blistering occur at the site of application, it is recommended to stop use and consult a physician.

No information is available regarding carcinogenicity, mutagenicity, or impairment of fertility. Furthermore, there is no data provided on animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep the product out of reach of children to prevent accidental ingestion. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should be informed to use the product only as directed and to read and follow all directions and warnings provided on the carton. It is important to emphasize that the product should not come into contact with the eyes or mucous membranes, as this may lead to irritation.

Healthcare providers should make patients aware that rare cases of serious burns have been reported with similar products. Therefore, patients should be cautioned against applying the product to wounds, damaged, broken, or irritated skin. Additionally, they should not bandage the area tightly or apply local heat, such as heating pads or medicated patches, to the site of application.

Patients should be advised not to use the product concurrently with other topical analgesics to avoid potential interactions. A transient burning sensation may occur upon application, but this typically resolves within several days. It is also recommended that patients avoid applying the product into skin folds and not to exceed the use of four patches at a time.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature, maintaining a range of 15° to 30°C (59° to 86°F). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

The product is administered topically, with a recommended application frequency of no more than 3 to 4 times daily to the affected area. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. Additionally, it is important to keep the product out of reach of children; if ingested, patients should seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Drug Information (PDF)

This file contains official product information for Asperflex Original Maximum Strength, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)